The study proposed here intends to evaluate the anti-HCV potential of fluoroquinolones on HCV-infected patients in a clinical trial, while taking into account the genotype differences relevant most to Pakistani population. We will focus on four fluoroquinolones that are found to be most potent in our in vitro experiments, and will explore the potential of these fluoroquinolones to inhibit HCV infection in Pakistani patients infected with genotype 3a. Fluoroquinolone drugs are already tested and approved for use on humans. They are commercially available and are commonly prescribed for the treatment of bacterial infections. The proposed study will help in identifying fluoroquinolones that may be used as a safer and inexpensive alternative to the current HCV treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014102619678N1
Registration date:2014-11-12, 1393/08/21
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-11-12, 1393/08/21
Registrant information
Name
Syed Hani Abidi
Name of organization / entity
Aga Khan University
Country
Pakistan
Phone
+922134864496
Email address
syed.abidi@aku.edu
Recruitment status
Recruitment complete
Funding source
Higher Education Commission, Pakistan
Grant number: 20-2267
Expected recruitment start date
2015-01-01, 1393/10/11
Expected recruitment end date
2015-06-01, 1394/03/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of fluoroquinolones in treating interferon non-responders infected with HCV genotype 3a
Public title
Fluoroquinolones as anti-HCV drugs
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
•Patient on IFN treatment who have not shown two-log reduction in their HCV load for 3 months
•HCV-RNA positive
•Infection with HCV genotype 3a
•Chronic hepatitis diagnosed by liver ultrasound
•Pre-cirrhotic, as determined by liver ultrasound
•Informed consent to participate in the study
Exclusion criteria:
•Known hypersensitivity to fluoroquinolones
•Infection with HCV genotype other than 3a
•Pregnant females
•Concurrent hepatitis B or HIV infection
•Carcinomatous changes on liver biopsy evident in liver ultrasound
•History of alcohol or intravenous drug abuse
•Disinclination to informed consent
Age
From 25 years old to 60 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Dow University of Health Sciences Institutional Review Board
Street address
Dow University of Health Sciences,
City
Karachi
Postal code
Approval date
2013-02-09, 1391/11/21
Ethics committee reference number
IRB-365/DUHS-2013
Health conditions studied
1
Description of health condition studied
Hepatitis C virus infection
ICD-10 code
B18.2
ICD-10 code description
Chronic viral hepatitis C
Primary outcomes
1
Description
Viral load
Timepoint
3 months post drug treatment
Method of measurement
Quantitative Real Time PCR for viral RNA
Secondary outcomes
1
Description
Liver function test and Complete Blood Count
Timepoint
Weekly throughout the drug treatment
Method of measurement
Clinical laboratory using automated testing units and microscopy
Intervention groups
1
Description
Intervention: Interferon therapy plus fluoroquinolone
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Qatar Hospital and Dow University of Health Sciences
Full name of responsible person
Dr Syed Ali/ Dr Syed Hani Abidi
Street address
City
Karachi
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Higher Education Commission, Pakistan
Full name of responsible person
Dr. Amjad Hussain
Street address
Research & Development Division, Higher Education Commission, Sector H-9, East Service Road
City
Islamabad
Grant name
Grant code / Reference number
20-2267
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Higher Education Commission, Pakistan
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Aga Khan University
Full name of responsible person
Syed Hani Abidi
Position
Post-doctoral fellow/PhD
Other areas of specialty/work
Street address
Stadium Road
City
Karachi
Province
Sind
Postal code
74800
Phone
00922134864496
Fax
Email
syed.abidi@aku.edu
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Aga Khan University
Full name of responsible person
Syed Hani Abidi
Position
Post-doctoral fellow/PhD
Other areas of specialty/work
Street address
Stadium Road
City
Karachi
Province
Sind
Postal code
74800
Phone
00922134864496
Fax
Email
syed.abidi@aku.edu
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Aga Khan University
Full name of responsible person
Syed Hani Abidi
Position
Post-doctoral fellow/PhD
Other areas of specialty/work
Street address
Stadium Road
City
Karachi
Province
Sind
Postal code
74800
Phone
00922134864496
Fax
Email
syed.abidi@aku.edu
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)